A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age
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|ClinicalTrials.gov Identifier: NCT03606512|
Recruitment Status : Active, not recruiting
First Posted : July 31, 2018
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus||Biological: Ad26.RSV.preF Biological: Placebo Biological: Nimenrix||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age|
|Actual Study Start Date :||January 21, 2019|
|Estimated Primary Completion Date :||November 2, 2020|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: Group 1: RSV Seronegative Toddlers (Ad26.RSV.preF)
Respiratory syncytial virus (RSV) seronegative toddlers will receive intramuscular (IM) injection of 2.5*10^10 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F-protein on Days 1, 29, and 57.
Ad26.RSV.preF will be administered as IM injection at a dose of 2.5*10^10 vp.
Other Name: JNJ-64400141
Placebo Comparator: Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix)
RSV seronegative toddlers will receive IM injection of placebo on Days 1, 29 and 57. Placebo can be replaced with Nimenrix on Day 57 in countries where applicable.
Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.
Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.
- Number of Participants with Solicited Local and Systemic Adverse Events (AEs) After Vaccination [ Time Frame: 7 days after each vaccination (up to Day 64) ]Number of participants with solicited local and systemic AEs will be evaluated. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and solicited systemic AEs (fatigue, headache, myalgia, arthralgia, chills, nausea and fever) will be noted in the participant diary after 7 days of each vaccination. Local and systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
- Number of Participants with Unsolicited AEs [ Time Frame: 28 days after each vaccination (up to Day 85) ]Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: First vaccination to the end of the study (approximately up to 26 months) ]Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
- Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A Strain [ Time Frame: Days 1, 8, 85, and 267 (End of season [EOS]) ]RSV neutralizing titers of the vaccine-induced immune response will be assessed for detection of neutralizing antibodies to RSV A strain.
- RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Days 1, 8, 85, and 267 (EOS) ]Antibodies binding to RSV F-protein in pre-fusion and post-fusion forms will be assessed by enzyme-linked immunosorbent assay (ELISA).
- T-Cell Responses Measured by Flow Cytometry (Intracellular cytokine Staining [ICS]) [ Time Frame: Days 1 and 85 ]T-cell responses to RSV F-protein peptides for T-helper cells (Th1/Th2) subtyping will be measured by flow cytometry (ICS).
- Number of Participants with Severe RSV-Lower Respiratory Tract Infection (LRTI) [ Time Frame: Approximately up to 26 months ]Number of participants with severe RSV-LRTI will be assessed. Severe RSV-LRTI will be defined as the presence of severe LRTI as assessed by the Clinical Endpoint Committee (CEC), and confirmation of RSV infection from a nasal (mid-turbinate or nasopharyngeal) sample using reverse transcriptase polymerase chain reaction (RT-PCR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606512
|Study Director:||Janssen Vaccines & Prevention B.V. Clinical Trial||Janssen Vaccines & Prevention B.V.|